NCT05185245招募中不适用
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.
Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.
Type of different transplantations proposed are as follows:
- Whole liver graft or partial liver (split) from a deceased donor
- Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.
In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
- •Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
- •No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
- •No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
- •Good performance status Eastern Cooperative Oncology Group 0 or 1
- •Neutrophils > 1.000
- •Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
- •Carcino-Embryonic Antigen < 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
- •Written informed consent
- •No other contraindications to liver transplantation
排除标准
- •Presence of other malignancies
- •Local recurrence of primary tumor
- •Extra-hepatic metastatic disease
- •Patients who did not receive any neoadjuvant or adjuvant therapy
- •Palliative resection of primary tumor
- •Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
结局指标
主要结局
Overall Survival
时间窗: 5 years
次要结局
- Disease-Free Survival(5 years)
研究者
研究点 (2)
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